Neupogen

What is Neupogen?

• Neupogen (filgrastim) is a leukocyte growth factor used to treat neutropenia (a condition in which there is a lower-than-normal number of white blood cells) caused by some types of chemotherapy.

Filgrastim

What are the uses of this medicine?

• Neupogen (filgrastim) is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

Neupogen is indicated to:

• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
• Reduce the time to neutrophil recovery and the duration of fever, following chemotherapy treatment of patients with acute myeloid leukemia (AML).
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
• Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

How does this medicine work?

• Filgrastim (fil gra' stim) is a recombinant, non-glycosylated form of the 175 amino acid protein, granulocyte colony stimulating factor (G-CSF) that induces the proliferation and maturation of neutrophils.
• G-CSF is normally produced by multiple cell types including monocytes, fibroblasts, macrophages and stromal cells.
• It acts on specific receptors found on granulocyte progenitors and causes an increase in circulating neutrophils.
• Recombinant filgrastim has been shown to increase total neutrophil counts and to protect, in part, against severe infections in patients with neutropenia for various causes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who are:

• serious allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim products.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Filgrastim was approved for use in the United States in 1991, and current indications are for chemotherapy induced neutropenia, in hematopoietic cell transplantation after myeloablation and in congenital and cyclic neutropenias.
• Filgrastim is also used in patients undergoing autologous peripheral blood progenitor (stem) cell collection.

How should this medicine be used?

Recommended dosage: Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML:

• Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

Patients with cancer undergoing bone marrow transplantation:

• 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. See Full Prescribing Information for recommended dosage adjustments and timing of administration.

Patients undergoing autologous peripheral blood progenitor cell collection and therapy:

• 10 mcg/kg/day subcutaneous injection.
• Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis.

Patients with congenital neutropenia:

• Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily.

Patients with cyclic or idiopathic neutropenia:

• Recommended starting dose is 5 mcg/kg subcutaneous injection daily.

Patients acutely exposed to myelosuppressive doses of radiation:

• 10 mcg/kg/day subcutaneous injection.

Administration:

• Neupogen injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If Neupogen is given at home, see the detailed "Instructions for Use" that comes with your Neupogen for information on how to prepare and inject a dose of Neupogen.
• Your healthcare provider will tell you how much Neupogen to inject and when to inject it. Do not change your dose or stop Neupogen unless your healthcare provider tells you to.
• If you are receiving Neupogen because you are also receiving chemotherapy, your dose of Neupogen should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your Neupogen dose.
• If you are receiving Neupogen because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with Neupogen to check your white blood cell count.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Vial:

• Injection: 300 mcg/mL in a single-dose vial
• Injection: 480 mcg/1.6 mL in a single-dose vial

Prefilled Syringe:

• Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe
• Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe

This medicine is available in fallowing brand namesː

• Neupogen

What side effects can this medication cause?

The most common side effects of this medicine include: Patients with cancer receiving chemotherapy:

• fever, pain, rash, cough, and shortness of breath

Patients with acute myeloid leukemia receiving chemotherapy:

• pain, nose bleed, and rash

Patients with cancer receiving chemotherapy followed by bone marrow transplant:

• rash

Patients who are having their own blood cells collected:

• bone pain, fever, and headache

Patients with severe chronic neutropenia:

• pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

Neupogen may cause serious side effects, including:

• Spleen rupture
• acute respiratory distress syndrome
• Serious allergic reactions
• Sickle cell crises
• glomerulonephritis
• Capillary leak syndrome
• Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)
• thrombocytopenia
• leukocytosis
• cutaneous vasculitis
• aortitis

What special precautions should I follow?

• Splenic rupture, including fatal cases, has been reported following the administration of Neupogen. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
• Acute respiratory distress syndrome (ARDS) has been reported in patients receiving Neupogen. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue Neupogen in patients with ARDS.
• Serious allergic reactions, including anaphylaxis, have been reported in patients receiving Neupogen. Permanently discontinue Neupogen in patients with serious allergic reactions.
• Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue Neupogen if sickle cell crisis occurs.
• Glomerulonephritis has occurred in patients receiving Neupogen. Evaluate and consider dose-reduction or interruption of Neupogen if causality is likely.
• Capillary leak syndrome (CLS) has been reported after G-CSF administration, including Neupogen, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
• Monitor patients with breast and lung cancer using Neupogen in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Thrombocytopenia has been reported in patients receiving Neupogen. Monitor platelet counts.
• Cutaneous vasculitis has been reported in patients treated with Neupogen. Hold Neupogen therapy in patients with cutaneous vasculitis. Neupogen may be started at a reduced dose when the symptoms resolve and the ANC has decreased.
• Aortitis has been reported in patients receiving Neupogen. It may occur as early as the first week after start of therapy.
• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Neupogen will harm your unborn baby.

Can this medicine be used in children?

• The safety and effectiveness of Neupogen have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: filgrastim
• Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection

Who manufactures and distributes this medicine?

Manufactured by:

• Amgen Inc., One Amgen Center Drive, Thousand Oaks, California U.S.A.

What should I know about storage and disposal of this medication?

• Store Neupogen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Keep Neupogen in the original carton to protect from light or physical damage.
• Do not leave Neupogen in direct sunlight.
• Do not shake Neupogen.
• Take Neupogen out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away (dispose of) any Neupogen that has been left at room temperature for longer than 24 hours.
• After you inject your dose, throw away (dispose of) any unused Neupogen left in the vials or prefilled syringes.
• Do not save unused Neupogen in the vials or prefilled syringes for later use.

• Dailymed label info on Neupogen
• FDA Neupogen

Neupogen Resources
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